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VirbacRilexine 600 mg for dogs over 40 kg 1 tablet

Treatment of bacterial skin infections and urinary-tract infections in dogs

Prescription required* (Exceptions apply)

Rilexine 600 mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Rilexine 600 mg

For one 1440-mg tablet: - active ingredient cefalexin (as cefalexin monohydrate) ..….. …600 mg For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM OF Rilexine 600 mg

Tablet Ovaloid, divisible, palatable tablet

4. CLINICAL PARTICULARS OF Rilexine 600 mg

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the treatment of bacterial skin infections in dogs (including deep and superficial pyodermas) caused by organisms susceptible to cefalexin. For the treatment of urinary-tract infections in dogs (including nephritis and cystitis) caused by organisms susceptible to cefalexin.

4.3 Contraindications

Do not use in animals which are known to be hypersensitive to penicillins and cephalosporins. Do not use in rabbits, guinea pigs, hamsters and gerbils.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

i. Special precautions for use in animals

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In case of known renal insufficiency, the dose should be reduced and antimicrobials known to be nephrotoxic should not be administered concurrently. This product should not be used to treat puppies of less than 1 kg of bodyweight. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with other cephalosporins and penicillins, due to the potential for cross-resistance. Use of the product should not be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.

ii. Special precautions for the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporin and vice versa. Allergic reaction sot these substances may occasionally be serious. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.Handle this product with great care to avoid exposure, taking all recommended precautions. Wash hands after use.If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

iii. Other precautions

None 4.6 Adverse reactions (frequency and seriousness)

Hypersensitivity to Cefalexin is rare, however, the product should not be administered to animals which are known to be hypersensitive to Cefalexin or penicillins. Refer also to section 4.3.

4.7 Use during pregnancy, lactation or lay

The product can be used in pregnant and lactating animals

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amount(s) to be administered and administration route

15 mg of cefalexin per kg of bodyweight twice daily (equivalent to 30 mg per kg of bodyweight per day) for a duration of: 14 days in case of urinary-tract infection;at least 15 days in case of superficial infectious dermatitis;at least 28 days in case of deep infectious dermatitis. To achieve this dosage, administer one tablet per 40 kg of bodyweight or ½ tablet per 20 kg of bodyweight. Any remaining ½ tablet should be safely stored in the original box in the opened blister. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing. Due to its palatable formulation, the product is well accepted by dogs but may be crushed or added to food if necessary. In severe or acute conditions, the dose may be safely doubled.

Trials performed on animals with up to 5 times the recommended dose of 15 mg/kg demonstrated that the product is well tolerated.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES OF Rilexine 600 mg

Pharmacotherapeutic group:

Antibacterial for systemic use, first-generation cephalosporins.

ATC Vet Code:

QJ01DB01

5.1 Pharmacodynamic properties

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins interfere with the enzymes of transpepditation making it unable to cross-link the peptidoglycans of the bacterial cell wall. The glycan cross-linking is essential for the cell to build its cell wall. Inhibition of the biosynthesis results to a weakened cell wall, which eventually ruptures to osmotic pressure. The combined action results in cell lysis and filament formation. Cefalexin is active against a wide range of gram-positive and gram-negative bacteria: Staphylococcus spp. (including penicillin-resistant strains), Streptococcus spp., Escherichia coli, Klebsiella spp. and Salmonella spp.. Cefalexin is not inactivated by b-lactamases produced by gram-positive bacteria and which usually affect penicillins.

5.2 Pharmacokinetic properties

After single oral administration of the recommended dosage of 15 mg of cefalexin per kg of bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The plasma peak was observed at 1.3 hour with a plasma concentration of 18.2 mg/ml. The bioavailability of the active was over 90 %. Cefalexin was detected until 24 hours after the administration. The first urine specimen was collected within 2 to 12 hours with peak concentrations of cefalexin measured at 430 to 2758 mg/ml within 12 hours. After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks occurred 2 hours later with a concentration of 20 mg/ml. Over the treatment period, concentrations were maintained above 1 mg/ml. The mean elimination half-life is 2 hours. Skin levels were around 5.8 to 6.6 mg/g, 2 hours after treatment.

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